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Eculizumab Pregnancy and Breastfeeding Warnings

Eculizumab is also known as: Soliris

Medically reviewed on Jul 31, 2018

Eculizumab Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned.

Risk Summary: There are no data on the use of this drug in pregnant women. It is a recombinant IgG molecule (humanized anti-C5 antibody) that is expected to cross the placenta.

-This drug may cause fetal harm.
-Women of childbearing potential should use adequate contraception during therapy and for up to 5 months after the last dose.
-A pregnancy exposure registry is available.

Animal studies show an increase in the rate of developmental abnormalities and fetal death at doses 2 to 8 times the recommended human dose. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. To enroll or obtain information, contact or

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Eculizumab Breastfeeding Warnings

Maternal dosages of this drug produce undetectable levels in breastmilk. Because it is a large protein molecule, absorption is unlikely because it is probably destroyed in the infant GI tract. No adverse effects attributable to this drug were reported in infants who were breastfed during maternal therapy.

-Breastfeeding should be discontinued during therapy and up to 5 months after treatment.
-According to some authorities, caution is recommended if this drug is taken while breastfeeding.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

-IgG is excreted into human milk, so it is expected that this drug will be present in human milk; however, antibodies in human milk do not enter the neonatal and infant circulation in substantial amounts.
-The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Soliris (eculizumab)." Alexion Pharmaceuticals Inc, Cheshire, CT.

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):
  2. "Product Information. Soliris (eculizumab)." Alexion Pharmaceuticals Inc, Cheshire, CT.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.